• Manage deployment of Global SDLC/CSA and IT Security policies and procedures.
• Ensure supply of all compliance components required to deliver high quality product through

tactical planning and execution of project and compliance deliverables, including change-control,

periodic reviews, performance monitoring, system administration, access administration, disaster

recovery, deviations, incident problem management/investigations, CAPAs, audits, policy

deployment, cyber security, data integrity, EHS, training etc.

• Ensure highest Quality, EHS & Compliance standards.
• Active participation in the Tier process and proactively resolving issues.
• Liaise with Compliance Engineers from other areas and support Site Quality Council and other site

quality initiatives.

• Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics
• Completion of AIT Investigations, root-cause analysis and CAPA’s

·Strong project management skills to support project delivery and operational readiness.

Desirable:

• At least 2 years experience in the planning, document generation, support or execution of CSV

activities in a biologic drug substance manufacturing plant.

• A thorough knowledge of regulatory requirements associated with computer systems including EU

GMP Annex 11, 21 CFR Part 11 is required.

• Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and

PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP

Environments).

• Experience in PLC/SCADA/DCS system

Contact George on 0871897038 or alternatively email me directly on GMcGlone@Horizon-controls.com